Monitoring and managing adverse reactions
The percentage of patients requiring Verzenio dose reductions due to adverse reactions was similar across trials: 44% in MonarchE, 43% in MONARCH 2 and MONARCH 3 and 49% in MONARCH 11
Dose modifications for adverse reactions
- If dose reduction is necessary, reduce the Verzenio dose by 50 mg at a time1
- Discontinue Verzenio for patients unable to tolerate 50 mg twice daily1
- Refer to the full Prescribing Information for coadminstered endocrine therapy for dose modifications and other relevant safety information
Dose modifications for use with strong and moderate CYP3A inhibitors1
- Avoid concomitant use of the strong CYP3A inhibitor ketoconazole
- With concomitant use of strong CYP3A inhibitors other than ketoconazole, in patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the Verzenio dose to 100 mg twice daily
- In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the Verzenio dose to 50 mg twice daily
- If a patient taking Verzenio discontinues a CYP3A inhibitor, increase the Verzenio dose (after 3 to 5 half-lives of the inhibitor) to the dose that was used before starting the strong inhibitor
- With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the Verzenio dose in 50 mg decrements if necessary
Dose modifications for patients with severe hepatic impairment1
- For patients with severe hepatic impairment (Child-Pugh Class C), reduce the Verzenio dosing frequency to once daily
- For patients with renal impairment1
- The pharmacokinetics of Verzenio in patients with severe renal impairment (CLcr <30 mL/min), end stage renal disease, or in patients on dialysis is unknown.
- No dosage adjustments are necessary in patients with mild to moderate renal impairment (CLcr ≥30-89 mL/min)
Refer to the full Prescribing Information for coadministered fulvestrant, tamoxifen, or the aromatase inhibitor for dose modifications and other relevant safety information.
- Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company.